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Clinical trial rules brought forward in Denmark

This article was originally published in Clinica

20 Nov 1995

News

Executive Summary

Problems encountered in Denmark with Boneloc bone cement have prompted the country's National Board of Health to bring forward the full implementation of the EU Medical Device Directive rules on clinical trials. Boneloc, a cement used to secure artificial hips and manufactured in Denmark by Polymers Reconstructive (a Biomet subsidiary), was associated with an abnormally high surgery revision rate earlier this year (see Clinica No 650/51, p 2). It was alleged to have crumbled in a large number of cases.